The U.S Food and Drug Administration has notified the manufacturers of fluroquinolone antimicrobial drugs that a "boxed warning" in the label of the product is required to inform patients of the increased risk of tendonitis and tendon rupture.
Aside from the boxed warning the FDA also decided that manufactures provide a Medication Guide to patients warning of the possible side effects. The drugs already carry a warning of an increased risk of tendon ruptures but an increased number of adverse event reports prompted the increased visibility of that warning.
The class of antimicrobial drugs known as fluroquinolones, such as Cipro, have been approved to treat or prevent bacterial infections such as sinusitus, urinary tract infections, cystitis and lower respiratory tract infections.
The drugs involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.
Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research stated, "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."
[Source: FDA]
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